Guide Wires for Cannulated Screws
FDA 510(k) K963432 · Orthopaedic Biosystems, Ltd.
510(k) numberK963432
Submission
- Device name
- Guide Wires for Cannulated Screws
- Applicant
- Orthopaedic Biosystems, Ltd.
Scotsdale, AZ, US - Received
- August 30, 1996
- Decision date
- November 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K112345 | Distal Volar Radius Plating SystemsLXT · Traditional | Medos International SARL | 10/31/2011SE |
| K090374 | Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…LXT · Special | DePuy Orthopaedics, Inc. | 03/11/2009SE |
| K073135 | Synthes (USA) Hybrid External Fixator ModificationsLXT · Traditional | Synthes (Usa) | 01/29/2008SE |
| K063832 | Synthes (USA) Elbow Hinge FixatorLXT · Traditional | Synthes (Usa) | 03/07/2007SE |
| K060864 | Multidirectional Threaded PegLXT · Special | Hand Innovations, LLC | 04/28/2006SE |
| K060403 | Pta (Progressive Tibial Alignment)LXT · Traditional | Meridian Medical | 03/28/2006SE |
| K060290 | Shoulder Fixation SystemLXT · Special | Hand Innovations, LLC | 02/27/2006SE |
More from Hand Innovations, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01JDR · Special | 04/03/2000SE |
| K982996 | Polymer Obl SB Anchor / Suture CombinationJDR · Traditional | 03/04/1999SE |
| K983169 | Polymer Threaded AnchorMBI · Traditional | 12/16/1998SE |
| K982963 | Polymer Threaded Anchor / Suture CombinationJDI · Traditional | 11/20/1998SE |
| K972326 | Peba Anchor/Suture CombinationMBI · Traditional | 02/06/1998SE |
| K963420 | Cancellous Screw WasherHTN · Traditional | 11/15/1996SE |
| K963433 | Threaded Fixation PinJDW · Traditional | 11/06/1996SE |
| K962779 | Compression ScrewHWC · Traditional | 08/23/1996SN |
| K951451 | Peba Anchor (Multiple Sizes)MBI · Traditional | 10/31/1995SN |
| K942889 | SB AnchorJDR · Traditional | 08/25/1995SE |
Questions and answers
When was Guide Wires for Cannulated Screws cleared by the FDA?
Guide Wires for Cannulated Screws (K963432) received a 510(k) decision of Substantially Equivalent on November 13, 1996, 75 days after the submission was received.
What is the product code of K963432?
The FDA product code is LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, a Class II (moderate risk) device regulated under 21 CFR 888.3030.